Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

iBio in pending deal to sell CDMO facility; extends Woodforest credit agreement

iBio (NYSEA:IBIO) announced a sixth amendment to its credit agreement with Woodforest National bank to allow sufficient time for the company to complete the pending sale of its cGMP biologics manufacturing facility. The...

September 22, 2023

Developments

IntelGenx receives first RIZAFILM purchase order from U.S. partner Gensco

IntelGenx (TSX:IGX; OTCQB:IGXT) reported that it received the first purchase order (PO) for RIZAFILM from its U.S. commercial partner, Gensco Pharma. The company expects to ship the order to Gensco in the first quarter...

September 21, 2023

Developments

Hepion’s rencofilstat demonstrates anti-cancer activity

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that rencofilstat demonstrated anti-cancer activity across 86% of cancer types in a high-throughput screen on 850 cancer cell lines. At the Broad Institute of MIT and...

September 21, 2023

Developments

IntelGenx receives FDA GDUFA date for partnered buprenorphine buccal film

IntelGenx’s (TSX:IGX; OTCQB:IGXT) buprenorphine buccal film – for which an amendment to the abbreviated to new drug application (ANDA) requesting priority review has been filed by Chemo Research through its agent and...

September 20, 2023

Developments

Hepion discovers novel rencofilstat action in liver cancer

Hepion Pharmaceuticals (NASDAQ:HEPA) reported new research findings that discovered a mechanism by which the company’s lead drug candidate, rencofilstat, may exert anti-cancer activity. The research examined...

September 20, 2023

Developments

Anixa forms cancer business advisory board

Anixa Biosciences (NASDAQ:ANIX) formed a cancer business advisory board (CBAB) with a roster of renowned cancer advocates, executives and physicians to guide the company’s clinical and business development...

September 19, 2023

Developments

Mati completes manufacturing facility; prepares for Phase 3 nepafenac trial

Closely-held Mati Therapeutics completed a dedicated manufacturing facility for products formulated using the company’s Evolute sustained ocular drug delivery platform. Mati expects that the 10,000-square-foot facility...

September 15, 2023

Developments

Hepion’s rencofilstat shows positive outcomes in idiopathic pulmonary fibrosis

Hepion Pharmaceuticals (NASDAQ:HEPA) reported positive findings from a translational research study assessing the effects of rencofilstat on lung tissue obtained from patients with idiopathic pulmonary fibrosis (IPF)...

September 14, 2023

Developments

OKYO completes enrollment in Phase 2 dry eye clinical trial

OKYO Pharma (NASDAQ:OKYO) completed full enrollment of patients in the randomized portion of the Phase 2 clinical trial of topical ocular, OK-101, to treat dry eye disease (DED). A total of 240 patients were enrolled in...

September 8, 2023

Developments

Rani posts successful drug delivery of high-capacity pill

Rani Therapeutics Holdings (NASDAQ:RANI) reported three new positive preclinical studies that support development of a high-capacity oral biologics device, known as the RaniPill HC, a version of the RaniPill capsule...

September 8, 2023

Developments

Opus Genetics doses first patient with gene therapy in LCAS

Closely-held Opus Genetics dosed the first patient in its Phase 1/2, first-in-human clinical trial of OPGx-LCA5, an adeno-associated virus 8 vector designed to precisely deliver a functional LCA5 gene to the outer...

September 7, 2023

Developments

Arcutis posts positive long-term roflumilast cream results in AD

Arcutis Biotherapeutics (NASDAQ:ARQT) reported positive interim results from the INTEGUMENT-OLE long-term, open-label study of roflumilast cream 0.15% in adults and children ages six years and older with atopic...

September 7, 2023

Developments

Cantor boosts biotech research with Josh Schimmer, Eric Schmidt

Cantor Fitzgerald bolstered its healthcare and biotech equity research team with the addition of Josh Schimmer, M.D., and Eric Schmidt, Ph.D. “Having two of the most highly regarded analysts in the biotechnology...

September 6, 2023

Developments

Palisade Bio in GI-licensing deal with Giliant Pharma

Palisade Bio (NASDAQ:PALI) entered into a licensing agreement with closely-held Giliant Pharma for the exclusive worldwide rights to develop, manufacture and commercialize Giiant’s proprietary targeted prodrug platform...

September 6, 2023

Developments

Tonix fails Phase 2 pain study; holds out hope in fatigue

Tonix Pharmaceuticals Holding’s (NASDAQ:TNXP) TNX-102 SL did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at week 14 in the Phase 2 PREVAIL study. However, TNX-102 showed...

September 5, 2023

Developments

Plus Therapeutics initiates Part B of ReSPECT-LM Phase 1/2a trial for LM

Plus Therapeutics (NASDAQ:PSTV) treated the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium obisbemeda for the treatment of leptomeningeal metastases (LM) from...

September 5, 2023

Developments

Sage in reorganization to support launch of ZURZUVAE, advance pipeline

Sage Therapeutics (NASDAQ:SAGE) plans to reorganize its business operations and pipeline priorities to support goals for long-term business growth, including the planned commercial launch of ZURZUVAE for women with...

August 31, 2023

Developments

Ampio Pharmaceuticals unveils reverse stock split

The board of Ampio Pharmaceuticals (NYSEA:AMPE) approved a 20-to-1 reverse stock split of the company’s common stock, to be effective at close on Sept. 11. Ampio’s common stock is expected to begin trading on a...

August 31, 2023

Developments

NRx Pharmaceuticals submits IND for chronic pain

NRx Pharmaceuticals (NASDAQ:NRXP) submitted an investigational new drug (IND) application to the FDA for the use of NRX-101 to treat chronic pain. The IND application leverages pioneering research on the use of D...

August 30, 2023

Developments

Outlook Therapeutics receives CRL in wet AMD

Outlook Therapeutics (NASDAQ:OTLK) received a complete response letter (CRL) to the company’s biologics license application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development...

August 30, 2023

Developments

Zealand Pharma gets FDA priority review in congenital hyperinsulinism

The FDA granted priority review designation for Zealand Pharma’s (NASDAQ:ZEAL; CVR-no. 20045078) dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with...

August 30, 2023

Developments

AEON presents positive Phase results in cervical dystonia

AEON Biopharma (NYSE:AEON) presented positive results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the...

August 29, 2023

iBio in pending deal to sell CDMO facility; extends Woodforest credit agreement

IntelGenx receives first RIZAFILM purchase order from U.S. partner Gensco

Hepion’s rencofilstat demonstrates anti-cancer activity

IntelGenx receives FDA GDUFA date for partnered buprenorphine buccal film

Hepion discovers novel rencofilstat action in liver cancer

Anixa forms cancer business advisory board

Mati completes manufacturing facility; prepares for Phase 3 nepafenac trial

Hepion’s rencofilstat shows positive outcomes in idiopathic pulmonary fibrosis

OKYO completes enrollment in Phase 2 dry eye clinical trial

Rani posts successful drug delivery of high-capacity pill

Opus Genetics doses first patient with gene therapy in LCAS

Arcutis posts positive long-term roflumilast cream results in AD

Cantor boosts biotech research with Josh Schimmer, Eric Schmidt

Palisade Bio in GI-licensing deal with Giliant Pharma

Tonix fails Phase 2 pain study; holds out hope in fatigue

Plus Therapeutics initiates Part B of ReSPECT-LM Phase 1/2a trial for LM

Sage in reorganization to support launch of ZURZUVAE, advance pipeline

Ampio Pharmaceuticals unveils reverse stock split

NRx Pharmaceuticals submits IND for chronic pain

Outlook Therapeutics receives CRL in wet AMD

Zealand Pharma gets FDA priority review in congenital hyperinsulinism

AEON presents positive Phase results in cervical dystonia

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